European Commission approves Roche's Susvimo for neovascular age-related macular degeneration
核心洞察
The European Commission has approved Roche's Susvimo, a refillable eye implant delivering a customised ranibizumab formulation, for neovascular age-related macular degeneration (搜索).
Approval rests on the pivotal Phase III Archway trial plus the Phase II Ladder study and the open-label long-term extension study Portal.
Archway showed vision outcomes equivalent to monthly intravitreal ranibizumab, and with two refills per year about 95% of patients needed no supplemental anti-VEGF treatment.
The European Commission has approved Roche's Susvimo for the treatment of neovascular age-related macular degeneration (搜索) (nAMD). The decision is based on data from three clinical studies in nAMD: the pivotal Phase III Archway study and two supportive studies, the Phase II Ladder trial and the open-label long-term extension study Portal.
In Archway, patients treated with Susvimo achieved and maintained vision outcomes equivalent to monthly intravitreal ranibizumab injections. Longer-term data from Portal showed vision was maintained for up to seven years. With two refills per year, approximately 95% of patients treated with Susvimo required no supplemental anti-VEGF treatment, and the therapy was generally well tolerated over the longer term.
Susvimo is delivered by the Contivue platform, which includes a refillable implant surgically inserted into the eye during a one-time outpatient procedure plus four ancillary devices to fill, insert, refill and remove the implant. The implant delivers a customised formulation of ranibizumab, a VEGF inhibitor designed to bind and inhibit VEGF-A (搜索), which differs from the ranibizumab intravitreal injection marketed as Lucentis. In the US, the devices and medicine are approved by the FDA as a single product for nAMD, diabetic macular edema (搜索) and diabetic retinopathy (搜索). Contivue with Susvimo is also approved for nAMD in Switzerland and Thailand.